FDA report on lack of sterility assurance from NuVision Pharmacy

FDA report “FDA is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

FDA investigators inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483 issued July 16, 2014). The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions.”